IDEB: Irinotecan Drug-Eluting Beads in Glioblastoma

• Research type

  Research Study

• Full title

  A Phase I Study of Intraparenchymal Therapy with Irinotecan Hydrochloride Drug-Eluting Beads (CM-BC2) as an Adjunct Therapy to Best Standard of Care in Patients with Recurrent, Surgically Resectable Glioblastoma Multiforme.

• IRAS ID

  78366

• Contact name

  Garth Cruickshank

• Sponsor organisation

  Biocompatibles UK Ltd

• Eudract number

  2011-000687-10

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Title: Irinotecan drug-eluting beads in the treatment of recurrent high grade glioma (HGG) Despite advances in standard therapy, including surgical resection followed by radiotherapy and chemotherapy, the prognosis for patients with HGG remains poor. For patients with recurrent disease, there is no established chemotherapy regimen available and patients are best treated within investigational clinical protocols. The purpose of this study is to evaluate a novel local therapy, irinotecan drug??eluting bead, in patients who have recurrent HGG that is suitable for surgical resection. The irinotecan-containing drug delivery beads will be delivered at the time of surgery by shallow injections into the brain tissue surrounding the area from where the brain tumour has been surgically removed. Once the beads are in place, it is hoped that the irinotecan will be slowly released from the beads to help destroy any remaining tumour cells after surgery either because they were not visible to the eye of the surgeon or were left intentionally because they infiltrated functionally important brain tissue. This research study is designed to assess the safety and effectiveness of irinotecan drug-eluting beads, given in addition to the current best standard of treatment. Irinotecan is approved for use in treating tumours, and has been used for many years. A maximum of 10 patients will take part in the study at Queen Elizabeth Hospital in Birmingham. Each patient will be followed for 6 months after the treatment. During this time patients will attend regular visits at the hospital for tests and procedures including:?½ A physical and neurological examination. ?½ Further MRI scans to assess how the brain tumour has responded to treatment. ?½ Basic blood tests. ?½ Blood anti-tumour drug (Irinotecan) levels. ?½ Assessments of overall condition (??performance status?)

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  11/SC/0433

• Date of REC Opinion

  6 Dec 2011

• REC opinion

  Further Information Favourable Opinion